AzTrials
AzTrials

Prostate CancerPhase 2/3PSMAcTIONNCT06780670

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

A Phase 2/3 study testing Investigators choice of SoC and AAA817 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 93 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Investigators choice of SoC and AAA817
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
93 sitesin 13 countries
Study dates
27 Feb 2025to 19 Jul 2033
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults ≥ 18 years of age.
  • ECOG performance status of 0 to 2.
  • histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
  • PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
  • castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  • Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
  • ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
  • eGFR as requested by the sponsor

Who cannot join

  • Any investigational agents within 28 days prior to the day of randomization.
  • Any 225Ac-based investigational compound used prior to the day of randomization.
  • Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
  • Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
  • Baseline xerostomia ≥ Grade 2 by CTCAE v.5
  • History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

93 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

93 sites in 13 countries

United States35 sites, 35 recruiting

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

    Christen Nicole Cooper Pope, +1 706 353 2990, npope@universitycancer.com

    Petros Nikolinakos

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Jalpa Patel, +1 404 778 1835, jalpa.r.patel@emory.edu

    Shahid Sattar Ahmed

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Michael Bonhomme, 617-632-5136, michael_bonhomme@dfci.harvard.edu

    Xiao Wei

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Ooviya Sathiyamoorthy, 617-643-9923, osathiya@bidmc.harvard.edu

    David J Einstein

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Paige Olson, 773-702-4848, paige.olson@bsd.uchicago.edu

    Mohammad Atiq

    Recruiting

  • Texas Oncology

    Dallas, Texas, 75251

    Marian Heaven, 512-427-9467, marian.heaven@usoncology.com

    Michael P Herman

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Jannae Foellmer, 303-385-2000, jannae.foellmer@usoncology.com

    Manojkumar Bupathi

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Kristi Ben-Barka, kristi.ben-barka@usoncology.com

    Gregory Scott Sibley

    Recruiting

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

    Sarah Faisal, sarah.faisal@us-uro.com

    Benjamin Martin

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Melanie Manning, Melanie.Manning@hhchealth.org

    Andrew Salner

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Marie Burton, mariburt@iu.edu

    Nabil Adra

    Recruiting

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

    Kelsey Schwensen, kschwensen@kumc.edu

    Xinglei Shen

    Recruiting

  • VA Greater LA Healthcare System

    Los Angeles, California, 90073

    Janake Wijesuriya, janake.wijesuriya@va.gov

    Gholam Reza Berenji

    Recruiting

  • East Jefferson Hospital

    Metairie, Louisiana, 70006

    Alexandra Lieberman, alexandra.lieberman@lcmchealth.org

    Alton Oliver Sartor

    Recruiting

  • Baptist Health South

    Miami, Florida, 33173

    Leslie Castaneda, leslie.castaneda@baptisthealth.net

    Adeel Kaiser

    Recruiting

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

    Nadia Thomas, nathomas@mcw.edu

    Deepak Kilari

    Recruiting

  • Utah Intermountain Medical Center

    Murray, Utah, 84107

    Becky Arroyo, becky.arroyo@imail.org

    David Gill

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Rebecca Floyd, 843-839-1679, rebecca.floyd@startresearch.com

    Neal D Shore

    Recruiting

  • Mount Sinai Hosp Med School

    New York, New York, 10029

    Ilda Bander, 212-241-8903, Ilda.Bander@mountsinai.org

    Randy Yeh

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68154

    Marlene Bridwell, 402-334-4773, mbridwell@nebraskacancer.com

    Samuel Mehr

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Joseph Guzzo, 407-303-3235, joseph.guzzo@adventhealth.com

    Ravi Shridhar

    Recruiting

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1207

    Pallavi Gautam, 650-493-5000, pallavi.gautam@va.gov

    Minal Vasanawala

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Mikayla Easterling, maeast@stanford.edu

    Hong Song

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Candice Schewbel, 215-728-3075, candice.schwebel@fccc.edu

    Matthew Zibelman

    Recruiting

  • Onco Hemato Asso of SW Virginia

    Roanoke, Virginia, 24014

    Natasha Holt, 540-774-8660, natasha.holt@usoncology.com

    David Buck

    Recruiting

  • Urology San Antonio

    San Antonio, Texas, 78229

    Sandra Davila, sandra.davila@usa-clinicaltrials.com

    Daniel Saltzstein

    Recruiting

  • Sansum Clinic

    Santa Barbara, California, 93105

    Jessica Wong, 805-563-5800, jessica.wong2@sutterhealth.org

    Gregg Newman

    Recruiting

  • Saint Johns Cancer Institute

    Santa Monica, California, 90404

    Joey Dumadag, 310-829-8569, joey.dumadag@providence.org

    Przemyslaw Twardowski

    Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

    Cierra Spikes, cspikes@honorhealth.com

    Michael Gordon

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

    Brianna Woo, bwoo@fredhutch.org

    Ruben Raychaudhuri

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97477

    Maxim Dimarco, mdimarco@oregonurology.com

    Bryan Mehlhaff

    Recruiting

  • WA Uni School Of Med

    St Louis, Missouri, 63110

    Collin Welch, 314-454-8293, c.welch@wustl.edu

    Jeff Michalski

    Recruiting

  • Associated Med Professionals of NY

    Syracuse, New York, 13210

    Nathan Forrest, nathan.forrest@ampofny.com

    Steven Finkelstein

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Tahrima Chowdhury, 718-920-6642, tahchowdhu@montefiore.org

    Benjamin A Gartrell

    Recruiting

  • New Jersey Urology LLC

    Voorhees Township, New Jersey, 08043

    Gabriela Mercado, 856-673-1613, gmercado3@nj-urology.com

    Gordon Brown

    Recruiting

Other trials in United States

China16 sites, 16 recruiting

  • Novartis Investigative Site

    Beijing, 100034

    Recruiting

  • Novartis Investigative Site

    Beijing, 100036

    Recruiting

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

    Recruiting

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025

    Recruiting

  • Novartis Investigative Site

    Guangzhou, 510060

    Recruiting

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006

    Recruiting

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200025

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200032

    Recruiting

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011

    Recruiting

  • Novartis Investigative Site

    Tianjin, 300300

    Recruiting

  • Novartis Investigative Site

    Tianjin, 300480

    Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

    Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

    Recruiting

  • Novartis Investigative Site

    Xian, Shanxi, 710032

    Recruiting

  • Novartis Investigative Site

    Xian, Shanxi, 710061

    Recruiting

Other trials in China

Japan11 sites, 11 recruiting

  • Novartis Investigative Site

    Chiba, 2608717

    Recruiting

  • Novartis Investigative Site

    Fukuoka, 8110213

    Recruiting

  • Novartis Investigative Site

    Fukuoka, 8120033

    Recruiting

  • Novartis Investigative Site

    Fukuoka, 8128582

    Recruiting

  • Novartis Investigative Site

    Fukushima, 9601295

    Recruiting

  • Novartis Investigative Site

    Ishikawa, 9208641

    Recruiting

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778577

    Recruiting

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047

    Recruiting

  • Novartis Investigative Site

    Kyoto, 6068507

    Recruiting

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648

    Recruiting

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004

    Recruiting

Other trials in Japan

Israel6 sites, 6 recruiting

  • Novartis Investigative Site

    Beersheba, 8457108

    Recruiting

  • Novartis Investigative Site

    Haifa, 3109601

    Recruiting

  • Novartis Investigative Site

    Jerusalem, 9112001

    Recruiting

  • Novartis Investigative Site

    Petah Tikva, 4941492

    Recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601

    Recruiting

  • Novartis Investigative Site

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

South Korea4 sites, 4 recruiting

  • Novartis Investigative Site

    Seoul, 03080

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

  • Novartis Investigative Site

    Seoul, 05505

    Recruiting

  • Novartis Investigative Site

    Seoul, 06591

    Recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

  • Novartis Investigative Site

    Taipei, 10002

    Recruiting

  • Novartis Investigative Site

    Taipei, 103616

    Recruiting

  • Novartis Investigative Site

    Taipei, 11217

    Recruiting

  • Novartis Investigative Site

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

Australia3 sites, 3 recruiting

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Novartis Investigative Site

    Herston, Queensland, 4029

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Malaysia3 sites, 3 recruiting

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46050

    Recruiting

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46150

    Recruiting

  • Novartis Investigative Site

    Putrajaya, Kuala Lumpur, 62250

    Recruiting

Other trials in Malaysia

Singapore3 sites, 3 recruiting

  • Novartis Investigative Site

    Singapore, 119228

    Recruiting

  • Novartis Investigative Site

    Singapore, 168583

    Recruiting

  • Novartis Investigative Site

    Singapore, 258499

    Recruiting

Other trials in Singapore

Switzerland3 sites, 3 recruiting

  • Novartis Investigative Site

    Basel, 4031

    Recruiting

  • Novartis Investigative Site

    Bellinzona, 6500

    Recruiting

  • Novartis Investigative Site

    Bern, 3010

    Recruiting

Other trials in Switzerland

Brazil2 sites, 2 recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-050

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 05652-000

    Recruiting

Other trials in Brazil

Mexico2 sites, 2 recruiting

  • Novartis Investigative Site

    Huxquilucan, 52763

    Recruiting

  • Novartis Investigative Site

    Mexico City, Mexico City, 14050

    Recruiting

Other trials in Mexico

Hong Kong1 site, 1 recruiting

  • Novartis Investigative Site

    Hong Kong, 999077

    Recruiting

Other trials in Hong Kong

About this study

Official title: PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.

Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Read the detailed description

Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.

Conditions
Prostate Cancer
Being tested
Investigators choice of SoC, AAA817
Keywords
post [177Lu]Lu-PSMA targeted therapy, PSMA-positive, mCRPC adults, Metastatic castration-resistant prostate cancer, AAA817, [225Ac]Ac-PSMA-617, PSMA-based targeted therapy, Standard of Care, SOC
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigators choice of SoCDrug

    The control treatment in Phase III is investigator's choice of SoC

  • AAA817Drug

    Also called [225Ac]Ac-PSMA-617)

    The investigational treatment is AAA817

  • AAA817Drug

    Also called [225Ac]Ac-PSMA-617)

    The investigational treatment is AAA817

  • AAA817Drug

    Also called [225Ac]Ac-PSMA-617

    Investigational treatment is the Dose B of AAA817

Study groups in NCT06780670
Study groupRoleWhat they receive
Phase II: AAA817 Dose BExperimentalAAA817 will be given for a number of cycles; a cycle = 8 weeks
Receives: Drug: AAA817
Phase III: Investigator's choice of SoCActive comparatorParticipants will be given Standard of Care (SOC) treatment per Investigator's choice.
Receives: Drug: Investigators choice of SoC
Phase II: AAA817 Dose AExperimentalAAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
Receives: Drug: AAA817
Phase III: Recommended Phase 3 Dose of AAA817ExperimentalRp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks
Receives: Drug: AAA817

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical response rate (Phase II)

    Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement

    Measured: from date of randomization up to approximately 24 months

  2. Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II

    Safety defined as the type, incidence and severity of AEs and SAEs, and deaths

    Measured: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later

  3. Tolerability of the proposed dose of AAA817- Phase II

    Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure

    Measured: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817

  4. Radiographic progression-free survival (rPFS)- Phase III

    Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis

    Measured: from date of randomization up to approximately 24 months

  5. Overall survival (OS)- Phase III

    Percentage of participants who are alive or who are lost to follow-up at the time of analysis

    Measured: from date of randomization up to approximately 24 months

Secondary outcomes (14)

  1. Radiographic progression-free survival (rPFS)- Phase II

    Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis

    Measured: from date of randomization up to approximately 24 months

  2. Progression free survival (PFS)- Phase II

    Percentage of Participants meeting Progression Free Survival

    Measured: from date of randomization up to approximately 24 months

  3. Overall response rate (ORR)- Phase II

    Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR)

    Measured: from date of randomization up to approximately 24 months

  4. Disease control rate (DCR)- Phase II

    Percentage of participants with BOR of CR, PR, stable disease (SD) or non-CR/non-PD

    Measured: from date of randomization up to approximately 24 months

  5. Overall survival (OS)- Phase II

    Percentage of participants who are alive or who are lost to follow-up at the analysis data cut-off

    Measured: from date of randomization up to approximately 24 months

  6. Progression free survival (PFS) -Phase III

    Percentage of participants with PFS -defined as the time from date of randomization to first documented progression

    Measured: from date of randomization up to approximately 24 months

  7. Overall response rate (ORR)- Phase III

    ORR is defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR)

    Measured: from date of randomization up to approximately 24 months

  8. Disease control rate (DCR) -Phase III

    DCR is defined as the percentage of participants with BOR of confirmed CR, PR, stable disease (SD) or Non-CR/Non progressive disease (PD)

    Measured: from date of randomization up to approximately 24 months

  9. Duration of response (DoR)- Phase III

    Percentage of participants with confirmed DoR defined as duration of time between the date of first documented response (CR or PR) and progression or death due to any cause, whichever occurs first.

    Measured: from date of randomization up to approximately 24 months

  10. Time to first radiographic soft tissue progression (TTSTP)- Phase III

    Percentage of participants with confirmed first radiographic progression in soft tissue

    Measured: from date of randomization up to approximately 24 months

  11. First symptomatic skeletal event (TTSSE)_Phase III

    Percentage of participants with confirmed skeletal event is defined as new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurs first

    Measured: from date of randomization up to approximately 24 months

  12. Prostate specific antigen (PSA) response -Phase III

    PSA50 is defined as the percentage of participants who achieved a confirmed ≥ 50% decrease from baseline

    Measured: from date of randomization up to approximately 24 months

  13. Patient reported disease related symptoms and health-related quality of life (HRQoL): Phase III

    Percentage of participants who had a Change from baseline on FACT-P Prostate Cancer Subscale (PCS)

    Measured: from date of randomization up to approximately 24 months

  14. Time to worsening on the Worst Pain: Phase III

    Time to worsening on the Worst Pain defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (brief pain inventory - short form (BPI-SF)) of at least 30% of baseline or minimum of 2 points increase from baseline, or death due to any cause, whichever occurs first. BPI-SF is a self-reported questionnaire to evaluate pain intensity (severity) and impact of pain on the participant's daily functioning (interference).

    Measured: from date of randomization up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start27 Feb 2025
  3. Primary completion27 Jun 2028 (estimated)
  4. Study completion19 Jul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
443 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780670
Sponsor's protocol ID
CAAA817A12201
Other IDs
2024-512342-42-00
Acronym
PSMAcTION
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Investigators choice of SoC and AAA817 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 93 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, China, Japan, Israel, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical response rate (Phase II) (time frame: from date of randomization up to approximately 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06780670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in